NCT01736644已完成不适用
A Prospective Randomized Control Trial to Compare the Aquamantys System With Standard Electrocautery in Reducing Blood Loss in Primary Total Knee Arthroplasty
Medtronic Surgical Technologies3 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 3
- 主要终点
- Blood Loss
研究概览
简要总结
This study will compare the clinical outcomes for patients undergoing a total knee replacement using a bipolar sealer, the Aquamantys® System, as compared to standard electrocautery. Total blood loss during the hospital stay and knee mobility and discharge factors will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥18 years of age
- •Patient has failed conservative therapy of osteoarthritis of the knee and has been listed to undergo primary TKA
- •Patient is willing and able to provide written informed consent.
- •Pre-assessment Haemoglobin ≥ 11.0g/dl
- •Patient is suitable to receive spinal anaesthesia with no peripheral nerve blocks
- •Patients willing to undergo blood transfusion
排除标准
- •Patients that are listed for unicondylar or revision TKA
- •Patients who are being converted from a previous high tibial osteotomy and a previous unicondylar knee arthroplasty
- •Fixed motor deficit thus affecting functional assessment of the knee
- •Patients presenting with a non-osteoarthritis degenerative knee diagnosis
- •Patients presenting with known contralateral knee osteoarthritis requiring simultaneous bilateral TKA
- •Patients presenting with a history of previous knee infection
- •Patients presenting with a pre-operative knee range of motion < 85°
- •Knee deformity greater than 20 degrees varus or valgus
- •Patients presenting with a history of bleeding disorders and/or are on chronic blood anticoagulation therapy
- •Patients with significantly impaired renal function (defined by EGFR >30)
- •Patients with allergy or sensitivity to non-steroidal anti-inflammatory drugs, ropivacaine, ketoprofen or adrenaline
- •Patients presenting with an internal cardiac defibrillator
- •Women who are pregnant
- •Evidence of active (systemic or local) infection at time of surgery
- •Patients who have habitual opioid use
- •Patients who have a psychiatric or mental illness which could impair the consent process or ability to complete patient-report questionnaires
- •Morbid obesity [BMI > 40]
- •Patients who are unwilling to undergo blood transfusion, if necessary
- •Patients who are receiving any implant used in conjunction with a customised-cutting block system
- •Any patient who cannot or will not provide written informed consent for participation in the study
- •Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
结局指标
主要结局
Blood Loss
时间窗: upto to 72 hrs after surgery
The primary outcome will be total blood loss throughout the hospital stay.
次要结局
- Rehabilitation(6-weeks)
研究者
研究点 (3)
Loading locations...
相似试验
Unknown
不适用
Comparison of Three Knee ReplacementsArthroplastyTotal Knee ReplacementOsteoarthritis, KneeNCT03339557Coxa, Hospital for Joint Replacement240
已完成
不适用
Study Comparing BoneMaster Hydroxyapatite Coating With Plasma-sprayed Hydroxyapatite Coating on Acetabular CupsArthropathy of HipNCT00859976Zimmer Biomet167
已完成
不适用
Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee ReplacementsOsteoarthritisNCT02157220The University of New South Wales77
Unknown
不适用
Randomised Controlled Trial PFC Versus CKS Total Knee ProsthesesOsteoarthritis, KneeNCT00228137Radboud University Medical Center90
已完成
不适用
Study to Evaluate ACB Versus FNB Early Postoperative Period Functional Outcomes After TKAArthroplasty, Replacement, KneeNerve BlockNCT02218814George Macrinici106